News
Replimune’s resubmission for RP1 for melanoma comes after the departures of FDA leaders in place at the time of the drug’s first two rejections. The FDA expects to hold an advisory committee meeting in late July.
FEATURED STORIES
Policymaking at FDA has been anything but business as usual under the Trump administration, but former regulators cite the agency’s new investigational new drug pilot program as a sign of normalcy.
The FDA’s recently altered outlook on the evidence required for approval of rare disease drugs could have immediate benefits for companies including Skyhawk Therapeutics, Capricor Therapeutics and Biohaven.
The FDA has so far secured 600 new hires and is looking for 1,600 more as interim leadership at the agency aims to rebuild the workforce and morale after more than a year of intense attrition.
FROM OUR EDITORS
Read our takes on the biggest stories happening in the industry.
If cell and gene therapy makers are going to achieve their mission to improve patients’ lives, the industry must come together to share information across stakeholders, from regulators to manufacturers to payers.
THE LATEST
Executives from the three largest pharmacy benefit manager companies testified Tuesday before Congress that rising drug prices in the U.S. are due to pharma companies taking advantage of market exclusivities and excessive charges.
Third Arc Bio, led by three former Johnson & Johnson executives, is advancing a portfolio of multifunctional antibodies for cancer and inflammatory and immune-mediated diseases.
Despite early 2024 optimism, BioSpace’s Job Market Trends report outlines a still sluggish situation in the biopharma industry, Novartis and J&J announce Q2 earnings, GLP-1 market leaders expand into China and the Cassava Sciences saga continues.
While supportive of Amylyx’s acquisition of a GLP-1 drug, analysts say the company’s future hinges on key upcoming readouts from multiple products in its pipeline.
In the largest study of its kind, GSK’s two-drug regimen Dovato demonstrated non-inferior efficacy compared to Gilead Sciences’ three-drug regimen Biktarvy for the treatment of HIV-1.
Merck’s clesrovimab lowered the risk of medically attended lower respiratory infections associated with RSV infection when used in infants, according to topline results announced Tuesday.
The acquisition of the contract development and manufacturing organization will allow Agilent Technologies to provide a one-stop source for gene-editing services for its customers.
Allarity Therapeutics announced Monday that the Securities and Exchange Commission has made a preliminary determination recommending an enforcement action against the company for alleged violations of federal securities laws.
The Department of Health and Human Services’ Office of the Inspector General found that bluebird bio’s fertility support program for its gene therapies could potentially violate federal anti-kickback statutes.
The South Korean company’s Epysqli is now FDA-approved for paroxysmal nocturnal hemoglobinuria and atypical hemolytic uremic syndrome in the U.S., having grabbed the lead in the Soliris biosimilar market in Europe.